The Pure-Play’s Guide To Branding Biosimilars
The Pure-Play’s Guide To Branding Biosimilars

In the face of patient and physician hesitance about the safety and efficacy of biosimilars, long-known innovator company brands reassure stakeholders of the company’s experience, quality, and reliability. But this begs the question, how do smaller biosimilar companies fit in?

  • Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare
    Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

    If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

  • Why Real-World Evidence Will Challenge Biosimilars
    Why Real-World Evidence Will Challenge Biosimilars

    Though there is already a vast amount of available biosimilar-related real-world evidence (or Big Data), the industry will face quite a few pitfalls in securing and interpreting this data.

  • How To “Think Bigger” About Biosimilars
    How To “Think Bigger” About Biosimilars

    Real-world evidence, or data from real-world practice and use outside of clinical trials during drug development, is steadily becoming a key complement to randomized clinical trials. As Quintiles' Nancy Dreyer said, “So far, we’ve been concentrating on how biosimilars are made and how they will affect patients. But we need to be thinking bigger.”

  • Trump/GOP Plans For Obamacare, Medicare, & Medicaid Have Far-Reaching Pharma Effects
    Trump/GOP Plans For Obamacare, Medicare, & Medicaid Have Far-Reaching Pharma Effects

    An ideology-driven rush to undo decades of healthcare policy — and the uncertainty this will create — presents real hazards for every segment of the U.S. healthcare system, including the pharmaceutical industry.

  • Top 5 Biosimilar Developments Of 2016
    Top 5 Biosimilar Developments Of 2016

    In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

  • What Biosimilars Need To Succeed In Clinical Practice
    What Biosimilars Need To Succeed In Clinical Practice

    A few weeks ago, I sat in on a webinar hosted by ProCE called “Biosimilars Out Of The Gate: What Are the Latest Developments?” Though the webinar was not directly targeting companies developing biosimilars, I felt some of the insights carried important implications for biosimilar makers.

  • How To Establish Sample Sizes For Process Validation Using LTPD Sampling
    How To Establish Sample Sizes For Process Validation Using LTPD Sampling

    The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of lot tolerance percent defective (LTPD) to establish sample sizes for process validation.

  • 21st Century Cures & FDA Implementation: 5 Important Takeaways For Biopharma Companies
    21st Century Cures & FDA Implementation: 5 Important Takeaways For Biopharma Companies

    Now that the 21st Century Cures bill has been signed into law — following a nearly three- year journey that included a fair number of detours and roadblocks — all eyes in the drug development world are shifting to FDA.  To the question “What now?”  FDA can answer: A great deal of work.

  • 2017 Biopharmaceutical Trends — Opportunities For The New Year
    2017 Biopharmaceutical Trends — Opportunities For The New Year

    Although change is constant, it generally comes very slowly to the highly regulated biopharma industry. Bringing a biologic to market can be a decades-long process, so tracking trends needs to take a long view. Based on decades of analysis, and findings from our 13th Annual Report of Biopharmaceutical Manufacturing, this article will outline some of the key factors affecting the industry today.

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BIOSIMILAR INSIGHTS

  • Seed Culture Expansion Process: Reduce Time And Maximize Utilization

    This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes. For creation of high-density cell banks, Chinese hamster ovary (CHO) cells were expanded using a bioreactor system operated in perfusion mode.

  • Improving Single-Use Film To Achieve Optimal Performance In Biomanufacturing

    The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.

  • Single-Use Extractables and Leachables: Alignment with the BPOG Protocol

    Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA), of which GE is a member, and suppliers have derived their own approaches to testing. For end users who are adopting single-use (SU) equipment as a manufacturing strategy, this situation becomes unwieldy. The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious.

  • Single-Use Technology And Sustainability: Quantifying The Environmental Impact

    As this shift to SUT continues, there is both an opportunity and an obligation to understand the sustainability impacts of that shift.

  • Environmental Life Cycle Assessment of Single-Use Technologies

    Single-use technologies offer an attractive option for biopharmaceutical manufacturing, but their environmental impact needs be considered.

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TRAINING COURSES

Using the ACE Program for FDA Imports – Ensuring Compliance & Speedy Product Delivery January 20, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
12th Annual Biosimilars Summit January 24 - 25, 2017
Alexandria, VA
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template January 30, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Stability Programs - Key Factors in Meeting FDA/ICH Expectations February 14, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Update to ICH GCP E6 (R2) – Final Changes and Implementation February 15, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Electronic Informed Consent (eIC): How The New FDA/OHRP Final Guidance Affects You February 22, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Laboratory Data Integrity: Current Expectations for OOS Result Investigations February 24, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
10th Annual Oncology Commercialization & Market Access February 28, 2017 - March 1, 2017
San Francisco, CA
BioTech Pharma Summit 2017 March 29 - 31, 2017
Porto
More Upcoming Courses
Anna Rose Welch article header

 EVENTS

Using the ACE Program for FDA Imports – Ensuring Compliance & Speedy Product Delivery January 20, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
12th Annual Biosimilars Summit January 24 - 25, 2017
Alexandria, VA
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template January 30, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Stability Programs - Key Factors in Meeting FDA/ICH Expectations February 14, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!

LIFE SCIENCE EVENTS

12th Annual Biosimilars Summit January 24 - 25, 2017
Alexandria, VA
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Stability Programs - Key Factors in Meeting FDA/ICH Expectations February 14, 2017
1pm-2:30pm EST, Online Training
More Events...

LIFE SCIENCE INDUSTRY EVENTS

12th Annual Biosimilars Summit January 24 - 25, 2017
Alexandria, VA
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Stability Programs - Key Factors in Meeting FDA/ICH Expectations February 14, 2017
1pm-2:30pm EST, Online Training
More Industry Events

ABOUT BIOSIMILAR DEVELOPMENT

Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.

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